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Isosense
EUDAMEDClass IIa (EU MDR)
Ref Powder Free Polyisoprene Sterile Surgical Gloves, Size 8.5 (1R-SG-119-WH)Model ISOSENSE
Identity
- Trade Name
- Isosense EUDAMED
- Device Name
- Powder Free Polyisoprene Sterile Surgical Gloves EUDAMED
- Model / Reference
- ISOSENSE EUDAMEDPowder Free Polyisoprene Sterile Surgical Gloves, Size 8.5 (1R-SG-119-WH) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08997030302179 EUDAMED
- Basic UDI-DI
- 899703030IRSGQS EUDAMED
- EMDN Code
- T01010203 POLYISOPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Isosense by PT. Medisafe Technologies — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 899703030IRSGQS | Class IIa | Active |
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Manufacturer
- Manufacturer
- PT. Medisafe Technologies
- EUDAMED SRN
- ID-MF-000017133
- Authorised Representative
- Theo Manufacturing B.V. NL-AR-000006691
Sources (2)
- EUDAMED 98095fc9-0890-4b12-bc5c-9571a02dbe5f 61 fields · synced Aug 4, 2026
- EUDAMED 98095fc9-0890-4b12-bc5c-9571a02dbe5f-1 61 fields · synced Jun 10, 2026